Post-Processing of the Inspection

The EDA Eorm 483 is used to log the observed GMP violations found by inspectors during the stay in the company (lOM, 2014, Chapter 5.2.3. seqq.) In principle, these observations are the result of subjective perceptions of the inspectors and can be based on misunderstandings, not fully clarified facts or faulty communication. Elowever, there can be justified objectively measurable facts that are consistently seen by inspectors and inspected company. 

Once an EDA Eorm 483 signed by the inspector is handed over to the management, only the written path can be taken to comment on the observations, to relativize, and to make suggestions for corrective and preventive measures. The expectation of the EDA is that 483 observations will be answered in writing within 15 working days. 

If there are observations on the FDA Form 483, those persons involved in the inspection should be consulted that have detailed knowledge about how it came to this observation and may have already used the opportunity during the inspection to discuss with the inspector any responses or actions. In the case of experienced inspectors, these estimates can be very helpful for the design of a suitable response strategy. 

The answers shall convince the FDA district office, from where the inspector was sent that the proposed action is likely to achieve compliance with applicable US laws. The answer should not only focus on short-term solutions, but also on a sustainable implementation of reasonable measures, because it is very likely that in a subsequent FDA inspection this topic will be revisited. 

If the submitted answer does not convince the FDA and it is suspected that the proposed measures are not sufficient to solve the problem, the FDA will generate a Warning Letter, which is published on the website of the FDA and contains the observations and the assessments of the FDA. When even the written replies to this Warning Letter do not convince, legal measures, such as stopping a submission, import ban, confiscation can be taken by the FDA. 

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